Skip to main content

Table 1 Inclusion and exclusion criteria

From: CoCStom trial: study protocol for a randomised trial comparing completeness of adjuvant chemotherapy after early versus late diverting stoma closure in low anterior resection for rectal cancer

Inclusion criteria

Exclusion criteria

▪ Temporary diverting stoma (independent from the stoma type)

▪ ASA >3

▪ Elective curative LAR with TME (laparoscopic, open or converted) after neoadjuvant therapy (long course chemoradiation or short-term radiotherapy - 5 × 5 Gy) for UICC II-III rectal cancer

▪ Inflammatory bowel disease

▪ No anastomotic leakage (endoscopic or contrast enema assessment of the anastomosis around day 7 after LAR)

▪ Contraindication to adjuvant chemotherapy arising after rectal cancer resection [15]

▪ Indication to undergo adjuvant chemotherapy (according to current German guidelines the pre-therapeutic stage serves as basis for the adjuvant treatment decision) [15]

▪ Disease progress to UICC IV under neoadjuvant therapy

▪ Patient has given written informed consent

▪ Immunocompromised patients (HIV-positive, patients currently under chemotherapy for other diseases or patients under immunosuppressive therapy, e.g. Prednisolone >10 mg)

▪ Age ≥18 years

▪ Participation in another intervention-trial with interference of intervention and outcome of this study

▪ Patient is able to cooperate (ability of subject to understand character and individual consequences of the clinical trial)

 
  1. HIV human immunodeficiency virus